June 2007 - Legal File

European Supplement Regulation: A ‘Top to Bottom’ Overview

By Jeffrey D. Knowles and Todd Halpern

Successfully marketing a product in the 25 member states comprising the European Union (EU) requires understanding: (1) the “top” - the relevant legislation of the centralized government of the EU, which must be applied by the regulatory authority of each member state; and (2) the “bottom” - additional requirements and/or prohibitions that the member state may impose upon products marketed and distributed within its borders. This month, we will discuss the rules relating to products sold as “food supplements.”

Many products sold in the United States as “dietary supplements” may be sold in the EU as “food supplements.”

The definition of a food supplement is similar to the U.S. definition of a dietary supplement. As set forth in the directive, a food supplement includes: “foodstuffs the purpose of which is to supplement the normal diet and which are concentrated sources of nutrients or other substances with a nutritional or physiological effect, alone or in combination, marketed in dose form….” In the same way that U.S. law distinguishes “dietary supplements” from “drugs,” the EU distinguishes “food supplements” from “medicinal products” by essentially examining whether or not the product is intended to treat or prevent disease. This distinction is critical, because medicinal products are subject to an entirely different regulatory regime that requires, among other things, a pre-market determination that the product is safe and effective for its intended use.

An important distinction between the U.S. and EU rules relates to the status of products claiming to affect the structure or any function of the human body (commonly known as structure/function claims). Whereas U.S. rules permit such claims (when substantiated), EU rules do not. In the EU, any substance that may be administered to human beings with a view to “modifying physiological functions” (i.e., a structure/function claim) is deemed a medicinal product and may not be sold as a food supplement.

The EU Directive specifies which food supplements may be sold in Europe by permitting only those vitamins and minerals that are included on a “positive list” of allowable substances.

The existence of this “positive list” represents perhaps the most significant distinction from U.S. laws and FDA regulations, which permit a dietary supplement to contain a vast array of dietary ingredients, including vitamins, minerals, herbs and amino acids, as long as no ingredient contained in the supplement renders it an “unreasonable or significant risk” to human health. Many ingredients commonly found in supplements sold in the United States may not be marketed in the EU under this directive, including several prevalent forms of vitamin E, selenium, chromium and calcium.

Some ingredients absent from this positive list temporarily continue to remain available in certain member states due to transitional provisions of the directive, which permit a member state to provide for variations from this list until January 1, 2010. For example, in the U.K., where several hundred ingredients commonly found in supplements are currently absent from the positive list, a substance may continue to be sold if a dossier has been submitted in any member state until either December 31, 2009 or earlier, if the European Food Safety Authority (EFSA) issues an unfavorable opinion on the particular ingredient(s) before that date. On January 1, 2010, the positive list will preempt member-state variances, meaning that no food supplement containing an ingredient absent from the positive list will be permitted in any member state. (Some member states have decided not to make any exceptions from the ban.)

The EU labeling rules may be divided into two categories: (1) required information and (2) prohibited information. Requirements generally are designed to ensure that consumers can identify the product as a supplement (as distinguished from, for example, a medicinal product), understand the quantity of each nutrient it contains in terms of the recommended daily amount, identify each ingredient it contains and understand any other information relating to the safety and effectiveness of the product. For example, the rules require that all supplements contain the term supplement, as well as any specifications concerning the nutrients in the supplement (e.g., the name of nutrients and the quantity in both a numerical form and as a percentage of the daily amount recommended). All labels must describe the recommended daily amount of the food supplement, warn of the risks to health if the recommended daily amount is exceeded and declare that use of the supplement is not beneficial as a substitute for a varied diet. In addition, the label must warn consumers to store the product out of the reach of young children and, if the presentation of the product is similar to that of a medicinal product, explicitly declare: This is not a medicinal product.

The prohibitions are similar to those in the U.S., ensuring that consumers are not misled into believing that a product has any value in preventing, treating or curing a human disease. Any suggestion that a product provides such a benefit renders it a “medicinal product” subject to a different, and much more restrictive, regulatory scheme. One important distinction between the U.S. and EU rules pertains to the EU’s specific concern (and disbelief) that a food supplement may suggest that it is a superior means for consuming essential nutrients. The EU directive specifically prohibits: “any mention stating or implying that a balanced and varied diet cannot provide appropriate quantities of nutrients in general.”

While disease treatment and similar claims cannot be made to promote a food supplement, certain types of “nutrition claims” and “health claims” are permitted. Broadly speaking, as in the U.S., no claim may be false or misleading. However, whereas U.S. law generally relies on regulatory agencies to interpret and enforce this general prohibition, EU law sets forth additional, more specific prohibitions. For example, a claim may not “give rise to doubt about the safety and/or the nutritional adequacy of other foods” and may not “encourage or condone excess consumption of a food.” Thus, “eat all you want and still lose weight” is unlawful, even if scientifically proven to be truthful.

Other rules for claims depend upon how the claim is characterized, whether as a: (1) “nutrition claim”; (2) “health claim”; or (3) “reduction of disease risk claim.” A “nutrition claim” is any claim that a food has particular beneficial nutritional properties due to the caloric value, nutrients or other substances that it provides or lacks. A “health claim” is any claim that suggests a relationship exists between the product and health. Finally, a “reduction of disease risk claim” includes any health claim suggesting that the product “significantly reduces a risk factor in the development of a human disease.” Broadly speaking, the rules differ as to the type of information that must be presented along with the claim as well as to the type of evidence that must support the claim. For example, a health claim may be made as long as it is based on generally accepted scientific evidence and is well understood by the average consumer, but a reduction of disease risk claim also must be accompanied by a statement, indicating that the disease has multiple risk factors and that altering one of these risk factors may or may not have a beneficial effect.

Despite facing significant opposition from members of the “health freedom” movement who passionately believe in an individual’s right to choose what he or she consumes to preserve their health, this regulatory regime is likely to remain in place for the foreseeable future. A vigorous legal challenge to the legislation recently failed, securing its place on the books. Marketers wishing to launch a product in any European member state must carefully consult both EU and member-state specific rules in order to ensure compliance and avoid legal penalties.

Jeffrey Knowles manages Venable LLP’s Government Division and heads the firm’s Advertising and Marketing Practice Group. He also is a member of Venable’s Executive Committee. He can be reached at (202) 344-4860. Todd Halpern is an attorney at Venable. He can be reached at (202) 344-4984.


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